BEUDAMED
    FDA Enforcement Class II Ongoing

    Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

    Recall: Z-1642-2023 · Reported June 7, 2023

    Enforcement

    Recall Number
    Z-1642-2023
    Event ID
    92003
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Medical Systems USA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2023
    Initiation Date
    May 18, 2023
    Classification Date
    May 26, 2023
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

    Reason

    1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

    Code Info

    Model Item No. UDI-DI VKMO 10000-USA 701070441 4058863153841 VKMO 11000-USA 701070445 4058863153889 All lots

    Distribution

    Domestic distribution nationwide.

    Quantity

    0 (US)